Official recall notice
FDA DeviceClass INotable
FDA Recall: Aurous Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20-01 GPN G47308 Sizing cathete
- Recall date
- 2026-05-13
- Brand
- Cook Incorporated
- Category
- Medical Device
- FDA class
- Class I
Why it was recalled
Hazard
Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result include increased procedural time, harms associated with device fragmentation/separation, and vessel injury. In a worst-case scenario, device fragmentation and separation may cause life-threatening harm or death.
Recommended action
What to do
271
Product description
Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result include increased procedural time, harms associated with device fragmentation/separation, and vessel injury. In a worst-case scenario, device fragmentation and separation may cause life-threatening harm or death.